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Recently, Roche antibody-drug conjugates (ADC) for injection Amy trastuzumab in the country's second listing application (related to the admissibility No.
JXSS2000016 / 17) was changed to "on track" in the state NMPA expected few days New indications will be approved
.
Enmetrastuzumab (ado-trastuzumab emtansine, Kadcyla) is an antibody-conjugated drug (ADC) jointly developed by Roche and ImmunoGen.
Trastuzumab, which is targeted by HER2, is a chemotherapeutic drug that inhibits microtubule aggregation.
Tanxin (DM1) is connected by thioether linker MCC
.
In February 2013, the drug was approved in the United States.
So far, Kadcyla has been approved for listing in more than 100 countries around the world
.
As the first single-agent ADC approved for the treatment of HER2-positive metastatic breast cancer that has previously received trastuzumab and taxane chemotherapy (alone or in combination), Kadcyla's sales have increased year by year after its launch, reaching 1.
In China, enmetrastuzumab was approved in January this year through the priority review method, and the indication is that it is used as a single drug after receiving a new adjuvant therapy based on taxanes combined with trastuzumab.
Adjuvant treatment for HER2-positive early breast cancer patients with invasive lesions still remaining, the product name is Hersele
.
As the first ADC approved in China, according to Meinenet data, the sales of Hersele in urban physical pharmacies in China will reach 184 million U.
At present, in 2021, a new round of adjustments to the medical insurance catalogue has begun, and it is expected that Hersele can enter the national medical insurance and benefit more patients
.
In addition, it is worth mentioning that at present, domestic companies have begun to deploy the enmetrastuzumab biosimilar market, such as Shanghai Pharmaceuticals, Hisun Pharmaceuticals, Hengrui Pharmaceuticals and Sansheng Guojian
A collection of 3 domestic ADC drugs, 2 imported and 1 domestically produced
Antibody-conjugated drug (ADC) is a type of targeted biologics composed of antibodies, linkers and cytotoxic drugs.
It combines the targeting ability of monoclonal antibodies, high selectivity, stability, and highly effective anti-cancer potential of loaded drugs.
, It can accurately distinguish normal cells and tumor cells, and target cytotoxic drugs to tumor cells, with extremely high killing ability
.
In recent years, ADC drugs have become a popular research and development track in the field of medicine
.
Since the first ADC was approved in 2000, 13 ADCs have been approved globally so far
However, there are currently only 3 ADCs approved in China, namely Roche's Enmetrastuzumab , Takeda's Vertuximab, and Rongchang Biologics' Verbutuximab
.
Among them, Verbutuximab is a CD30-targeted ADC, which is formed by coupling a monoclonal antibody targeting CD30 protein and a microtubule disrupting agent through a protease-sensitive cross-linking agent.
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